NCT04697251

Brief Summary

The aim of this study is the implementation of Forced Oscillations Technique (FOT) in newborns and small infants using a novel commercially available device. The objective is to assess the feasibility of the method, provide normative data for the first months of life and describe short- and long-term changes in neonatal respiratory disorders. The study population will consist of term and preterm newborns admitted to the Neonatal Intensive Care Unit (NICU) or the Well-Baby Nursery of the University Hospital of Patras, Greece. It is estimated that 200 full-term and 150 preterm newborns will be enrolled during a period of 36 months (March 2021 - September 2022). Measurements will be performed using the TremoFlo N-100 via a face mask, with the infant in the supine position during natural sleep. At least 3 technically acceptable measurements (duration 10s each) will be obtained, as follows:

  • Healthy full-term neonates: postnatal days 1, 2, 3 and at discharge
  • Preterm neonates: NICU admission, postnatal days 1, 2 and 3, and on the first day of each additional gestational week until discharge All participants will be also measured at the age of 3, 6 and 12 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

January 2, 2021

Last Update Submit

April 27, 2021

Conditions

Respiratory Function TestsRespiratory DiseaseInfant, Newborn, Disease

Outcome Measures

Primary Outcomes (26)

  • Respiratory resistance (Rrs) - Term newborns

    Rrs at multiple frequencies (FOT) in term infants

    Postnatal day 1.

  • Respiratory resistance (Rrs) - Term newborns

    Rrs at multiple frequencies (FOT) in term infants

    Postnatal day 2.

  • Respiratory resistance (Rrs) - Term newborns

    Rrs at multiple frequencies (FOT) in term infants

    Postnatal day 3.

  • Respiratory resistance (Rrs) - Term newborns

    Rrs at multiple frequencies (FOT) in term infants

    On the day of discharge.

  • Respiratory reactance (Xrs) - Term newborns

    Xrs at multiple frequencies (FOT) in term infants

    Postnatal day 1.

  • Respiratory reactance (Xrs) - Term newborns

    Xrs at multiple frequencies (FOT) in term infants

    Postnatal day 2.

  • Respiratory reactance (Xrs) - Term newborns

    Xrs at multiple frequencies (FOT) in term infants

    Postnatal day 3.

  • Respiratory reactance (Xrs) - Term newborns

    Xrs at multiple frequencies (FOT) in term infants

    On the day of discharge

  • Respiratory resistance (Rrs) - Preterm newborns

    Rrs at multiple frequencies (FOT) in preterm infants

    At NICU admission (within the first 2 hours).

  • Respiratory resistance (Rrs) - Preterm newborns

    Rrs at multiple frequencies (FOT) in preterm infants

    Postnatal day 1.

  • Respiratory resistance (Rrs) - Preterm newborns

    Rrs at multiple frequencies (FOT) in preterm infants

    Postnatal day 2.

  • Respiratory resistance (Rrs) - Preterm newborns

    Rrs at multiple frequencies (FOT) in preterm infants

    Postnatal day 3.

  • Respiratory resistance (Rrs) - Preterm newborns

    Rrs at multiple frequencies (FOT) in preterm infants

    On the first day of each additional week until 36 weeks post-conceptional age.

  • Respiratory resistance (Rrs) - Preterm newborns

    Rrs at multiple frequencies (FOT) in preterm infants

    On the day of discharge.

  • Respiratory reactance (Xrs) - Preterm newborns

    Xrs at multiple frequencies (FOT) in preterm infants

    At NICU admission (within the first 2 hours).

  • Respiratory reactance (Xrs) - Preterm newborns

    Xrs at multiple frequencies (FOT) in preterm infants

    On postnatal day 1.

  • Respiratory reactance (Xrs) - Preterm newborns

    Xrs at multiple frequencies (FOT) in preterm infants

    On postnatal day 2.

  • Respiratory reactance (Xrs) - Preterm newborns

    Xrs at multiple frequencies (FOT) in preterm infants

    On postnatal day 3.

  • Respiratory reactance (Xrs) - Preterm newborns

    Xrs at multiple frequencies (FOT) in preterm infants

    On the first day of each additional week until 36 weeks post-conceptional age.

  • Respiratory reactance (Xrs) - Preterm newborns

    Xrs at multiple frequencies (FOT) in preterm infants

    On the day of discharge.

  • Respiratory resistance (Rrs) - Infancy

    Rrs at multiple frequencies (FOT) during infancy

    At the age of 3 months (+/- 1 week)

  • Respiratory resistance (Rrs) - Infancy

    Rrs at multiple frequencies (FOT) during infancy

    At the age of 6 months (+/- 1 week)

  • Respiratory resistance (Rrs) - Infancy

    Rrs at multiple frequencies (FOT) during infancy

    At the age of 12 months (+/- 2 weeks)

  • Respiratory reactance (Xrs) - Infancy

    Xrs at multiple frequencies (FOT) during infancy

    At the age of 3 months (+/- 1 week)

  • Respiratory reactance (Xrs) - Infancy

    Xrs at multiple frequencies (FOT) during infancy

    At the age of 6 months (+/- 1 week)

  • Respiratory reactance (Xrs) - Infancy

    Xrs at multiple frequencies (FOT) during infancy

    At the age of 12 months (+/- 2 weeks)

Study Arms (1)

FOT measurements

OTHER

FOT measurements in newborns and small infants

Diagnostic Test: FOT measurements in newborns and small infants

Interventions

FOT measurements in newborns and small infantsDIAGNOSTIC_TEST

Measurements will be performed using the device TremoFlo N-100, at bedside, with the infant in the supine position during quiet natural sleep. After proper cleaning and decontamination, the face mask of the device will be preheated at 37oC (to avoid awakening) and will be placed on infant's face. The duration of each measurement will be predetermined at 10 s. At least 3 technically acceptable measurements will be performed per infant, with 30 s intervals between them. The validity of each measurement will be assessed according to the coherence function (automatically determined by the operating system of the device).

FOT measurements

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Newborns cared for in the NICU and well-baby nursery of the University Hospital of Patras, Greece.
  • Parental written informed consent.

You may not qualify if:

  • Major respiratory, cardiovascular or other condition that does not permit FOT measurements at the predetermined time points.
  • Any infectious disorder with increased risk of contamination.
  • Orofacial anomalies (e.g. genetic syndromes) that do not permit proper application of the face mask.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neonatal Intensive Care Unit, University Hospital of Patras

Pátrai, 26504, Greece

RECRUITING

Well-baby nursery, Department of Pediatrics, University Hospital of Patras

Pátrai, 26504, Greece

RECRUITING

Related Publications (4)

  • Skylogianni E, Douros K, Anthracopoulos MB, Fouzas S. The Forced Oscillation Technique in Paediatric Respiratory Practice. Paediatr Respir Rev. 2016 Mar;18:46-51. doi: 10.1016/j.prrv.2015.11.001. Epub 2015 Nov 10.

    PMID: 26777151BACKGROUND

  • Hantos Z, Czovek D, Gyurkovits Z, Szabo H, Maar BA, Radics B, Virag K, Makan G, Orvos H, Gingl Z, Sly PD. Assessment of respiratory mechanics with forced oscillations in healthy newborns. Pediatr Pulmonol. 2015 Apr;50(4):344-52. doi: 10.1002/ppul.23103. Epub 2014 Aug 25.

    PMID: 25154334BACKGROUND

  • Gray DM, Czovek D, McMillan L, Turkovic L, Stadler JAM, Vanker A, Radics BL, Gingl Z, Hall GL, Sly PD, Zar HJ, Hantos Z. Intra-breath measures of respiratory mechanics in healthy African infants detect risk of respiratory illness in early life. Eur Respir J. 2019 Jan 31;53(2):1800998. doi: 10.1183/13993003.00998-2018. Print 2019 Feb.

    PMID: 30464010BACKGROUND

  • Klinger AP, Travers CP, Martin A, Kuo HC, Alishlash AS, Harris WT, Carlo WA, Ambalavanan N. Non-invasive forced oscillometry to quantify respiratory mechanics in term neonates. Pediatr Res. 2020 Aug;88(2):293-299. doi: 10.1038/s41390-020-0751-7. Epub 2020 Jan 14.

    PMID: 31935746BACKGROUND

MeSH Terms

Conditions

Respiration DisordersDisease

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sotirios Fouzas

    University of Patras

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sotirios Fouzas, MD, PhD

CONTACT

6944510047sfouzas@upatras.gr

Gabriel Dimitriou, MD, PhD

CONTACT

gdim@upatras.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

January 2, 2021

First Posted

January 6, 2021

Study Start

April 1, 2021

Primary Completion

September 1, 2022

Study Completion

March 1, 2023

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

No Ethics Committee approval

Locations

GR(2)